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Dr. Margaret Hamburg 6 articles

Compounding pharmacy recalls products due to mold contamination

Med Prep Consulting, Inc., a compounding pharmacy based in Tinton Falls, NJ, is recalling all products after mold was discovered floating in plastic infusion bags. The mold was discovered in five bags of magnesium sulfate 2GM in Dextrose 5% in water, 50ml for injection, a product used for magnesium electrolyte replacement. If an intravenous product found to contain mold is injected into a patient, it could have deadly results. In an abundance of caution, Med Prep Consulting has recalled all products compounded by the pharmacy due to lack of sterility assurance. The affected products are administered for a wide range ... Read More

FDA cracks down on deceptive advertising of drugs

In early 2009, Bayer HealthCare Pharmaceuticals launched a $20 million advertising campaign for its blockbuster birth control pill, Yaz. The ads carried the same message: “You may have seen some Yaz commercials recently that were not clear. The FDA wants us to correct a few points in those ads.” What the Food and Drug Administration (FDA) wanted Bayer to clarify are what the agency considers misleading statements about the drug’s ability to improve women’s moods and clear up acne while downplaying the drug’s potential health risks. Yaz, also known as Yasmin or the generic Ocella, is currently being blamed for ... Read More

FDA cracks down on misleading drug promotions

Dr. Margaret Hamburg, the newly appointed chief of the Food and Drug Administration (FDA), is flexing her muscles with drug makers over questionable product promotion, in an effort to live up to her promise to step up enforcement of oversight of drug makers, device manufacturers and other companies the agency oversees. Last year, the FDA issued 41 enforcement letters, twice as many as it issued in 2008. “We’re trying to get the point across to industry that we want them to comply with the law because it affects public health,” Thomas Abrams, head of the FDA’s Drug Marketing, Advertising and ... Read More

H1N1 vaccine coming at pivotal time

“We are now in a position never before experienced in the history of influenza,” said Dr. Margaret Hamburg, Commissioner of Food and Drugs, in a letter to health care providers about the safety and availability of the 2009 H1N1 influenza vaccine. Just as a new and serious virus is spreading widely around the country, causing hospitalizations and deaths, a vaccine is becoming available to help prevent infection and protect the public.” More than 41 million doses of the 2009 H1N1 vaccine have been allocated to the United States for distribution, with more coming available daily. But a gap still remains ... Read More

Obama's pick for FDA commissioner wants to restore trust in agency

President Barack Obama’s top pick for Food and Drug Administration (FDA) commissioner, Bioterrorsim expert and former New York City health commissioner Dr. Margaret Hamburg, says that she wants to restore public confidence in the FDA, according to Boston.com. She already has Senator Edward M. Kennedy’s support. “Her expertise is valuable for problems we now face, such as combating food-borne illness, cooperating with other agencies to address the new flu outbreak and drug-resistant diseases, and protecting our food and drug supplies,” Sen. Kennedy said in a statement for the Health, Education, Labor, and Pensions Committee hearing. If confirmed, one of Dr. ... Read More

Hamburg hopes to create a culture in FDA where concerns are heard

President Barack Obama’s top pick for Food and Drug Administration (FDA) commissioner, Bioterrorsim expert and former New York City health commissioner Dr. Margaret Hamburg, says if confirmed she would “create a culture (at the agency) that would enable all voices to be heard,” according to Thompson, a human resources Web site. The comment was made during a question-and-answer exchange with Sen. Barbara Mikulski (D-Md) during the 1 ½-hour confirmation hearing. Mikulski asked Dr. Hamburg if she would heed concerns made by whistleblowers, such as those made by a group of employees at the Center for Devices and Radiological Health that ... Read More